Ireland
--:--IST
Recruiting Phase 2

An Exploratory Efficacy and Safety Study of DFL24498 Topical Ophthalmic Solution Compared With Vehicle in Participants With Dry Eye Disease

NCT07503886 · tracked via the Priya Life Science USA tracker
Phase
Phase 2
Started
2026-05-12
Last updated
2026-10-22

Condition(s) studied

Dry Eye Disease (DED)

Investigational drug(s) / intervention(s)

DFL24498 →Vehicle

DFL24498: One drop of reconstituted DFL24498 will be instilled topically in each eyes 4 times a day (QID) for 12 weeks.

Vehicle: One drop of reconstituted Vehicle will be instilled topically in each eyes QID for 12 weeks.

Study summary

This is a Phase 2, randomized, multicenter, double masked, vehicle controlled, parallel group study to evaluate the efficacy and safety of DFL24498 topical ophthalmic solution versus vehicle in participants with dry eye disease. Approximately 417 participants aged 18 years or older who meet all eligibility criteria will be enrolled at study sites in the US. The study duration will be up to 16 weeks and will consist of three periods.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Key Inclusion Criteria: * A diagnosis of DED at least 6 months before enrollment (current use or recommended use of artificial tears for the treatment of dry eye). * The global score of the SANDE questionnaire ≥ 30 * DED in at least one eye which is characterized by the following clinical features: 1. Schirmer I test without anesthesia \< 10 mm/5 minutes, and 2. Total CFS grade ≥ 4 assessed by the NEI grading system, and 3. Fluorescein tear film break-up time (TFBUT) \< 10 seconds. * Best corrected visual acuity (BCVA) score on early treatment of diabetic retinopathy study (ETDRS) chart of ≥ 35 letters (corresponding to ≥ 0.1 Snellen decimal units or ≤ 1.0 Logarithm of the Minimum Angle of Resolution (Chart) \[LogMAR\]) in each eye at the time of study enrollment. * Only participants who satisfy all informed consent requirements will be included in the study. Key Exclusion Criteria: * Inability to speak and understand the local language sufficiently to understand the nature of the study, to provide written informed consent, and to allow the completion of all study assessments. * Evidence of an active ocular infection in either eye. * Anticipated need for ocular surgery during the study period, or any prior ocular surgery for 6 months prior to screening. * Intraocular inflammation defined as anterior chamber cell or flare \> 0 by Standardization of Uveitis Nomenclature (SUN) grading in either eye. * Known or suspected ocular malignancy (ocular surface, intraocular, ocular adnexa) in either eye. Note: Additional protocol defined Inclusion/Exclusion criteria apply.

Primary outcome measure(s)

  • Change from baseline in corneal fluorescein staining (CFS) assessed by National Eye Institute (NEI) scale (0 to 15) in the Study Eye — Baseline to Week 12
    Fluorescein will be applied to the inferior fornix of the palpebral conjunctiva of each eye. To avoid the phenomenon of quenching, staining will be assessed within 1 to 4 minutes from fluorescein instillation. The CFS is performed at the slit lamp with blue (cobalt) light. The staining is graded using the NEI scale, which scores five corneal zones from 0 to 3 (total corneal score 0-15) with higher scores indicating more extensive staining.

Trial sites (24)

FacilityCityRegionStatus
Arizona Eye Center Chandler Arizona Recruiting
Canyon City Eyecare Azusa California Recruiting
Global Research Management, Inc. Glendale California Recruiting
United Medical Research Institute Inglewood California Recruiting
LoBue Laser and Eye Medical Center Murrieta California Not Yet Recruiting
Eye Research Foundation Newport Beach California Recruiting
NVision Clinical Research, LLC Torrance California Recruiting
Shettle Eye Research, Inc. Largo Florida Not Yet Recruiting
University of South Florida - Marshall Student Center Tampa Florida Not Yet Recruiting
Clayton Eye Clinical Research Morrow Georgia Recruiting
Price Vision Group / Cornea Research Foundation of America Indianapolis Indiana Recruiting
Minnesota Eye Consultants Minnetonka Minnesota Not Yet Recruiting
Tekwani Vision Center St Louis Missouri Not Yet Recruiting
Comprehensive Eye Care, Ltd. Washington Missouri Not Yet Recruiting
Asheville Eye Associates - Regional Medical Park Asheville North Carolina Not Yet Recruiting
Oculus Research, Inc. Garner North Carolina Recruiting
Core, Inc. Shelby North Carolina Not Yet Recruiting
Cincinnati Eye Institute Mason Ohio Not Yet Recruiting
Scott & Christie and Associates, PC Cranberry Township Pennsylvania Recruiting
Total Eye Care, PA - Memphis Memphis Tennessee Recruiting
Houston Eye Associates Houston Texas Not Yet Recruiting
Lake Travis Eye and Laser Center Lakeway Texas Recruiting
Alpine Research Organization, Inc. Clinton Utah Not Yet Recruiting
Piedmont Eye Center Lynchburg Virginia Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07503886 on ClinicalTrials.gov ↗ ← All trials in the USA